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Intracerebral HemorrhagePhase 2INFINITENCT07583147

Role of Neuroinflammation and Blood-Brain Barrier Breakdown in Intracerebral Hemorrhage.

A Phase 2 study testing TEP with 18F-DPA-714 injection in people with Intracerebral Hemorrhage, run by University Hospital, Toulouse at 3 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

In this prospective, multicenter study of patients with acute spontaneous supratentorial Intracerebral Hemorrhage (ICH), each participant will have a standardized multimodal evaluation of neuroinflammation at 10 (±2) days after onset including translocator protein 18 kDa (TSPO) positron emission tomography (PET) using… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intracerebral Hemorrhage
What is being tested?
TEP with 18F-DPA-714 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
117 participants
Where
3 sitesFrance
Study dates
Jun 2026to Dec 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults (≥ 18 years old);
  • presenting with a symptomatic spontaneous supratentorial ICH;
  • ICH within 48 hours after symptoms onset (or last seen well);
  • ICH confirmed by brain imaging;
  • Informed consent documented;
  • Affiliated or beneficiary of social security scheme.

Who cannot join

  • Massive ICH volume (≥ 60 ml) at admission;
  • Severe coma (defined as a Glasgow Coma Scale score < 6) at admission;
  • Planned neurosurgical hematoma evacuation;
  • Decision already taken for palliative care with withdrawal of active treatment;
  • Pre-existing dependance defined as a mRS score ≥2 prior to ICH occurrence;
  • Underlying secondary cause of ICH including macrovascular causes (brain arteriovenous malformation, intracranial aneurysm, dural arteriovenous fistula, cavernous malformation), brain tumour, cerebral venous thrombosis, hemorrhagic infarction. Patients taking oral anticoagulant can be included;
Show all 15Show fewer
  • TSPO genotyping demonstrating a low affinity binder profile,
  • Unable to tolerate or contraindicated to brain MRI: medical material not MRI compatible, claustrophobia, known hypersensitivity to gadoteric acid, meglumin or any drug containing gadolinium;
  • Estimated glomerular filtration rate < 30 ml/min/1.73 m 2
  • Unable to tolerate or contraindicated to 18F-DPA714 PET: women who are pregnant or breastfeeding, claustrophobia, and known hypersensitivity to DPA-714;
  • Use of Benzodiazepines within 7 days (within 6 weeks for prazepam, diazepam or clorazepate) preceding TSPO PET acquisition;
  • Co-existing neuroinflammatory disease such as Multiple Sclerosis, Neuromyelitis optica, Neurosarcoidosis, autoimmune encephalitis, CNS vasculitis;
  • Conditions requiring long-term immunosuppressive medication;
  • Expected impossible follow-up or poor compliance;
  • Patient under tutorship, curatorship, or legal protection.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Nicolas RAPOSO, MD, PHD contact

05 61 77 76 40 ext. 33

raposo.n@chu-toulouse.fr

France3 sites

  • CHU de Bordeaux

    Bordeaux, 33000

    Igor Sibon, MD, PHD, .5.56.79.55.20 ext. 33, igor.sibon@chu-bordeaux.fr

  • CHU de montpellier

    Montpellier, 34000

    Adrien Ter Schiphorst, MD, .4.67.33.67.33 ext. 33, adrien.ter.schiphorst@gmail.com

  • CHU de Toulouse

    Toulouse, 31000

    Nicolas Raposo, MD, PHD, 5 61 77 76 40 ext. 33, raposo.n@chu-toulouse.fr

Other trials in France

About this study

In this prospective, multicenter study of patients with acute spontaneous supratentorial Intracerebral Hemorrhage (ICH), each participant will have a standardized multimodal evaluation of neuroinflammation at 10 (±2) days after onset including translocator protein 18 kDa (TSPO) positron emission tomography (PET) using 18F-DPA-714 radioligand, BBB imaging using Dynamic contrast-enhanced (DCE)-MRI and a panel of pro-inflammatory and anti-inflammatory plasma biomarkers.

Read the detailed description

Intracerebral Hemorrhage (ICH) is the most devastating stroke subtype that affects > 3 million people worldwide each year. Despite important efforts and the hope that minimally invasive surgical procedures may offer, there is currently no effective treatment. Perihematomal edema - a surrogate marker of neuroinflammation - has emerged as important contributors to poor functional outcome following acute ICH, and a potential treatment target. Innovative techniques have been developed to image and measure neuroimmune response (TSPO PET) and BBB integrity (DCE-MRI). These novel methods have been poorly studied in ICH. The effects of in vivo perihematomal neuroinflammation on the functional outcome of patients with acute ICH is widely unknown.

The present study is a prospective, multicenter study of patients with acute spontaneous supratentorial ICH (within 48h after onset). Each participant will have a standardized multimodal evaluation of neuroinflammation at 10 days after onset including TSPO PET using 18F-DPA-714 radioligand, BBB imaging using DCE-MRI and a panel of pro-inflammatory and anti-inflammatory plasma biomarkers.

In hospital follow up visit will occur at 14 days and end of follow up visit at 180 days. Functional outcome will be assessed by modified Rankin scale (mRS), which is a widely used and validated scale - ranging from 0 (no symptoms) to 6 (death) - to evaluate the functional outcome following ischemic or hemorrhagic strokes.

Being tested
TEP with 18F-DPA-714 injection
Medical subject headings
Cerebral Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TEP with 18F-DPA-714 injectionDrug

    TEP with 18F-DPA-714 injection

Study groups in NCT07583147
Study groupRoleWhat they receive
18F-DPA-714 PET radiotracer uptake within the perihematomal edemaExperimental18F-DPA-714 injection for TEP
Receives: Drug: TEP with 18F-DPA-714 injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 18F-DPA-714 PET radiotracer uptake at day 10 ±2 after ICH according to the functional outcome (poor versus favorable) at 6 months

    • 18F-DPA-714 binding is measured by the mean standard uptake value ratio (SUVR) within the perihematomal edema (PHE) using the mirror region of interest (ROI) in the contralateral hemisphere as reference.
    • The functional outcome at 6 months after ICH is quantified by the modified Rankin scale (which ranges from 0 [no symptoms] to 6 [death]). Poor functional outcome is defined as a modified Rankin scale score (mRs) ≥3

    Measured: o 18F-DPA-714 binding is measured at day 10 ±2 after ICH. o The functional outcome is measured at 6 months after ICH

Secondary outcomes (8)

  1. Volume of brain tissue with increased 18F-DPA-714 PET radiotracer uptake at day 10 ±2 after ICH according to the functional outcome (poor versus favorable) at 6 months

    • 18F-DPA-714 binding is measured by the mean standard uptake value ratio (SUVR). Volume of brain tissue (mL) with increased 18F-DPA-714 binding is measured in the area around the hematoma.
    • The functional outcome at 6 months after ICH is quantified by the modified Rankin scale (which ranges from 0 [no symptoms] to 6 [death]). Poor functional outcome is defined as a modified Rankin scale score (mRs) ≥3

    Measured: o 18F-DPA-714 binding is measured at day 10 ±2 after ICH o The functional outcome is measured at 6 months after ICH

  2. 18F-DPA-714 PET radiotracer uptake at day 10 ±2 after ICH according to the occurrence of neurological deterioration within 14 days after ICH onset

    • 18F-DPA-714 binding is measured by the mean standard uptake value ratio (SUVR) within the perihematomal edema (PHE) using the mirror region of interest (ROI) in the contralateral hemisphere as reference.
    • Neurological deterioration within 14 days after ICH onset is defined as a ≥4-point increase on the National Institutes of Health Stroke Scale (NIHSS) or ≥2-point decrease on the Glasgow Coma Scale (GCS) compared to baseline scores at the pre-inclusion visit

    Measured: o 18F-DPA-714 binding is measured at day 10 ±2 after ICH. o Neurological deterioration is assessed within 14 days after ICH onset

  3. 18F-DPA-714 PET radiotracer uptake at day 10 ±2 after ICH according to the occurrence of early death

    • 18F-DPA-714 binding is measured by the mean standard uptake value ratio (SUVR) within the perihematomal edema (PHE) using the mirror region of interest (ROI) in the contralateral hemisphere as reference.
    • Early death is defined as death at day 30 after ICH onset.

    Measured: o 18F-DPA-714 binding is measured at day 10 ±2 after ICH. o Early death is assessed within 30 days after ICH onset.

  4. 18F-DPA-714 PET radiotracer uptake at day 10 ±2 after ICH according to the clinical outcome at 6 months

    • 18F-DPA-714 binding is measured by the mean standard uptake value ratio (SUVR) within the perihematomal edema (PHE) using the mirror region of interest (ROI) in the contralateral hemisphere as reference.
    • Clinical outcome at 6 months is assessed by the distribution of modified Rankin scale scores

    Measured: o 18F-DPA-714 binding is measured at day 10 ±2 after ICH. o Clinical outcome is assessed et 6 months

  5. 18F-DPA-714 PET radiotracer uptake at day 10 ±2 after ICH according to the mortality

    • 18F-DPA-714 binding is measured by the mean standard uptake value ratio (SUVR) within the perihematomal edema (PHE) using the mirror region of interest (ROI) in the contralateral hemisphere as reference.
    • Mortality is assessed at 6 months.

    Measured: o 18F-DPA-714 binding is measured at day 10 ±2 after ICH. o Mortality is assessed at 6 months.

  6. Correlations of 18F-DPA-714 PET radiotracer uptake at day 10 ±2 after ICH with MRI-derived measures of BBB breakdown and plasma levels of inflammatory biomarkers

    • 18F-DPA-714 binding is measured by the mean standard uptake value ratio (SUVR) within the perihematomal edema (PHE) using the mirror region of interest (ROI) in the contralateral hemisphere as reference.
    • BBB breakdown is quantified by MRI-derived quantitative measures based on maps of the contrast agent transfer coefficient (Ktrans) in the perihematomal area at day 10 ±2 after ICH;
    • Plasma levels of inflammatory biomarkers (including MMP9, TNF alpha, , IL-6 and -10, soluble TLR 2/4, Neutrophil Extracellular Traps (NETs) are measured at day 10 ±2 after ICH onset.

    Measured: PET, MRI and plasma inflammatory biomarkers measures are evaluated at day 10 ±2 after ICH onset

  7. BBB breakdown at day 10 ±2 after ICH according to the functional outcome (poor versus favorable) at 6 months

    • BBB breakdown is quantified by MRI-derived quantitative measures based on maps of the contrast agent transfer coefficient (Ktrans) in the perihematomal area at day 10 ±2 after ICH;
    • The functional outcome at 6 months after ICH is quantified by the modified Rankin scale (which ranges from 0 [no symptoms] to 6 [death]). Poor functional outcome is defined as a modified Rankin scale score (mRs) ≥3

    Measured: o MRI-derived quantitative measures of BBB breakdown are assessed at day 10 ±2 after ICH. o The functional outcome is measured at 6 months after ICH.

  8. Plasma levels of inflammatory biomarkers at day 10 ±2 after ICH according to the functional outcome (poor versus favorable) at 6 months

    • Plasma levels of inflammatory biomarkers (including MMP9, TNF alpha, , IL-6 and -10, soluble TLR 2/4, Neutrophil Extracellular Traps (NETs) are measured at day 10 ±2 after ICH onset;
    • The functional outcome at 6 months after ICH is quantified by the modified Rankin scale (which ranges from 0 [no symptoms] to 6 [death]). Poor functional outcome is defined as a modified Rankin scale score (mRs) ≥3

    Measured: o Plasma inflammatory biomarkers measures are assessed at day 10 ±2 after ICH. o The functional outcome is measured at 6 months after ICH.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionSep 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
117 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07583147
Sponsor's protocol ID
RC31/24/0443
Other IDs
2025-521923-58-00, 2025
Acronym
INFINITE
Status last verified
May 2026
First submitted
26 Jan 2026
Last updated
13 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TEP with 18F-DPA-714 injection in people with Intracerebral Hemorrhage, run by University Hospital, Toulouse at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nicolas RAPOSO, MD, PHD (05 61 77 76 40 ext. 33, raposo.n@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

18F-DPA-714 PET radiotracer uptake at day 10 ±2 after ICH according to the functional outcome (poor versus favorable) at 6 months (time frame: o 18F-DPA-714 binding is measured at day 10 ±2 after ICH. o The functional outcome is measured at 6 months after ICH). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07583147.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.

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